Details

Autor(en) / Beteiligte

• Dupont, Christophe, MD, PhD
• Kalach, Nicolas, MD, PhD
• Soulaines, Pascale, RN
• Legoué-Morillon, Sandrine, MD
• Piloquet, Hughes, MD
• Benhamou, Pierre-Henri, MD

Titel

Cow's milk epicutaneous immunotherapy in children: A pilot trial of safety, acceptability, and impact on allergic reactivity

Ist Teil von

• Journal of allergy and clinical immunology, 2010-05, Vol.125 (5), p.1165-1167

Ort / Verlag

New York, NY: Mosby, Inc

Erscheinungsjahr

2010

Quelle

Elsevier ScienceDirect Journals

Beschreibungen/Notizen

• Without any skin preparation or adjuvant, the EDS Viaskin allows dissemination of the allergen to the immune cells of the stratum corneum without systemic diffusion of the intact allergen.6 This first investigation in children with cow's milk allergy shows that EPIT using the EDS is virtually devoid of serious systemic AEs, which differs from subcutaneous and oral immunotherapies.2,3 The active treatment was associated with more frequent complaints for local pruritus and discomfort than placebo, but this did not lead to treatment interruption. Adverse events No. of patients with symptoms/total no. of patients[low *] No. of doses with symptoms/total no. of doses applied Risk of symptom occurrence (%) (95% CI) No. of patients with symptoms/total no. of patients[low *] No. of doses with symptoms/total no. of doses applied Risk of symptom occurrence (%) (95% CI) Active vs placeboOR (95% CI) P value Skin disorders 5/10 93/470 19 (16-23) 6/8 46/316 15 (11-19) 1.47 (0.95-2.08) .07 Local pruritus 3 54/470 11 (8-14) 2 38/316 12 (8-15) 0.95 (0.61-1.48) .81 Local eczema 2 39/470 8 (5-10) 1 3/316 1 (<0.5-1) 8.20 (2.72-24.5) <.001 Cutaneous rash 0 0/470 -- 1 3/316 1 (<0.5-1) 0.10 (0.01-1.95) .03 Face oedema 0 0/470 -- 1 1/316 1 (<0.5-1) 0.22 (0.01-5.45) .22 Urticaria 0 0/470 -- 1 1/316 1 (<0.5-1) 0.22 (0.01-5.45) .22 Respiratory/ENT disorders 2/10 2/470 1 (<0.5-1) 4/8 5/316 2 (<0.5-1) 0.30 (0.07-1.35) .09 Asthma 1 1/470 1 (<0.5-1) 2 3/316 1 (<0.5-1) 0.29 (0.04-1.97) .15 Cough 0 0/470 -- 0 0/316 -- -- -- Larynx pain 0 0/470 -- 1 1/316 1 (<0.5-1) 0.22 (0.01-5.45) .22 Bronchitis 1 1/470 1 (<0.5-1) 0 0/316 -- 2.02 (0.08-49.40) .41 Rhinitis 0 0/470 -- 0 0/316 -- -- -- Sneezing 0 0/470 -- 0 0/316 -- -- -- Conjonctivitis 0 0/470 -- 1 1/316 1 (<0.5-1) 0.22 (0.01-5.45) .22 Gastrointestinal disorders 1/10 16/470 3 (1-5) 0/8 0/316 -- 22.98 (1.36->100) <.001 Diarrhea 1 16/470 3 (1-5) 0 0/316 -- 22.98 (1.36->100) <.001 Vomiting/abdominal pain 0 0/470 -- 0 0/316 -- -- -- Other disorders 1/10 6/470 1 (<0.5-1) 1/8 1/316 1 (<0.5-1) 2.94 (0.50-17.46) .16 Fever 1 6/470 1 (<0.5-1) 1 1/316 1 (<0.5-1) 2.94 (0.50-17.46) .16 Totals